Practical preparation of compliant, sound documentation for drug- device combination products
Webcode 26112456
Dr. Matthias Kühnle
Freelance Health Care Consulting, Hochdorf, GERMANY
Consultant, Owner Retail Pharmacies After completing his studies in pharmacy, Dr Kühnle held various positions in the CMC and RA departments at Teva ratiopharm. His main areas of focus included the creation and consolidation of modules 2.3 and 3, as well as the coordination of interface issues between R&D, QA, CMC, and RA. This was followed by positions as team leader for Non-EU Regulatory Affairs and deputy head of the Regulatory Affairs department at Wörwag Pharma GmbH & Co. KG. Since 2017, Dr Kühnle has been working as an independent consultant specializing in global drug regulatory affairs, CMC, and interface issues between RA-QA and the pharmaceutical industry point of sale (pharmacies). He has also been the owner and manager of the Kirch Pharmacy in Hochdorf since 2017, and in 2020 and 2023 he took over the Eberhard Pharmacy in Notzingen and the Alb Pharmacy in Schlierbach as the new owner.
Dr. Jan Zaloga
Zaloga Consulting, Ehningen, GERMANY
Contract Auditor, Principal Quality Advisor
Dr Jan Zaloga works as an auditor and independent consultant specialising in quality management, GMP and regulatory matters within the pharmaceutical and medical technology sectors. He has over ten years’ professional experience in senior roles at both large corporations and SMEs, as well as advising international clients. His work focuses on the interface between medicines and medical devices, encompassing the establishment and further development of quality management systems, ensuring regulatory compliance, audits and preparation for inspections, as well as the implementation of regulatory requirements within complex organisations. Thanks to his strong background in operational business and experience gained from numerous audits, he combines regulatory expertise with a deep understanding of operational processes. As a pharmacist with a PhD, he explains complex regulatory topics in a practical, solution-oriented manner, with a focus on the demands of day-to-day work.
More information please click here.
24/11/2026
24/11/2026
from 9:00 am to 5:00 pm CET - online training
You may dial in 30 minutes before the lecture starts
online
online
Event - 1,290€ plus tax
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Event - 1,290€ plus tax
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
The EU regulatory landscape for drug-device combination products is highly demanding. This seminar walks you through the regulatory landscape, from MDR, EU GMP, and ICH guidelines to marketing authorisation and conformity assessment, equipping you with practical strategies for building compliant, submission-ready dossiers.
Drug-device combination products sit at the intersection of two highly complex regulatory worlds. Knowing how to navigate and combine the very different regulatory requirements for medicinal products and medical devices is becoming increasingly critical. In this seminar, you will gain a practice-oriented understanding of the EU regulatory landscape, from key guidelines and marketing authorisation to conformity assessment and documentation strategy. Through real-world case studies, you will learn how to structure compliant, submission-ready dossiers and confidently manage common pitfalls in your day-to-day work.
After having participated, you will be equipped with
Welcome, introduction, expectations
Bio break
Lunch break
Recap and pending questions
End of the seminar
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